Cosmetics FDA Compliance
Navigate the Modernization of Cosmetics Regulation Act (MoCRA) requirements. From facility registration to adverse event reporting, we cover everything cosmetic brands need to know about FDA compliance.
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Understanding MoCRA: A New Era for Cosmetics
The Modernization of Cosmetics Regulation Act (MoCRA), enacted on December 29, 2022, represents the most significant update to US cosmetic regulations in over 80 years. For the first time, FDA has meaningful authority to regulate cosmetics, including mandatory registration, product listing, adverse event reporting, and the ability to issue recalls.
Prior to MoCRA, cosmetics were largely self-regulated, with FDA only able to act against products after they caused harm. Now, manufacturers must proactively demonstrate safety, register facilities, list products, and report serious adverse events to FDA. Our MoCRA compliance guide covers every obligation in detail.
MoCRA affects virtually every cosmetic business operating in the US market, from small indie brands to global corporations. Foreign manufacturers exporting to the US must also comply, including registering facilities and designating US Agents. Use our MoCRA Readiness Checker to assess your compliance status, or try the Ingredient Safety Checker to evaluate your formulations.
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Key MoCRA Requirements
These are the core compliance requirements under MoCRA that cosmetic companies must meet.
Facility Registration
All cosmetic facilities must register with FDA under MoCRA (FD&C Act Section 607)
Product Listing
All cosmetic products must be listed with FDA
Adverse Event Reporting
Serious adverse events must be reported to FDA
Safety Substantiation
Responsible person must ensure product safety
MoCRA Implementation Timeline
Key dates for MoCRA compliance requirements.
Labeling Requirements
Cosmetic labels must include specific information in the required format.
Label Requirements
INCI Names Required
Ingredients must be listed using International Nomenclature of Cosmetic Ingredients (INCI) names in descending order of predominance.
Drug Claims Prohibited
Cosmetics cannot claim to treat, cure, or prevent disease. Claims like "anti-aging" or "treats acne" can cause a product to be regulated as a drug.
Frequently Asked Questions
Get answers to the most common questions about cosmetic FDA compliance under MoCRA.
What is MoCRA and how does it change cosmetic regulations?
The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 is the most significant update to US cosmetic regulations since 1938. It gives FDA new authority over cosmetics including: mandatory facility registration and product listing, adverse event reporting requirements, mandatory recalls, records access, and GMP requirements.
Who needs to register their facility under MoCRA?
Any facility that manufactures or processes cosmetics for distribution in the US must register with FDA (required since July 2024). This includes domestic facilities, foreign facilities exporting to the US, and contract manufacturers. Small business exemptions (under $1M annual sales) expired in December 2025 -- all companies must now comply.
What cosmetic products must be listed?
All cosmetic products distributed in the US must be listed with FDA, including products sold directly to consumers and professional products sold to salons. The listing must include: product name, category, list of ingredients, and responsible person information.
What is a 'serious adverse event' under MoCRA?
A serious adverse event is a health-related event caused by a cosmetic that results in: death, life-threatening experience, inpatient hospitalization, persistent or significant disability, congenital anomaly, or requires medical/surgical intervention to prevent these outcomes.
Our Cosmetic Compliance Services
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State-Level Requirements
In addition to federal MoCRA obligations, cosmetic companies must navigate state-level regulations that may impose additional requirements. State requirements exist alongside — not instead of — federal MoCRA compliance, and companies selling nationwide must meet both.
California has been at the forefront of cosmetic safety regulation with its Safe Cosmetics Act, and other states are following suit with their own ingredient disclosure and safety requirements.
SB 484 — Safe Cosmetics Act
California's Safe Cosmetics Act requires cosmetic manufacturers to report products containing ingredients known or suspected to cause cancer, birth defects, or reproductive harm to the California Department of Public Health (CDPH).
- Ingredient reporting to CDPH
- Covers carcinogens and reproductive toxicants
- Applies to products sold in California
- Separate from federal MoCRA requirements
Important Note
State requirements exist alongside federal MoCRA regulations — not as alternatives. Companies must comply with both. Other states including New York, Oregon, and Washington have introduced or enacted additional cosmetic safety legislation.
Related Resources
MoCRA Compliance Guide
Prepare for MoCRA requirements: registration, labeling, safety substantiation, and more.
Cosmetics US Agent Services
US Agent designation for cosmetic facilities under MoCRA. Responsible Person support included.
Ingredient Safety Checker
AI-powered ingredient risk assessment for cosmetics, food, and supplements.
Cosmetics MoCRA Transition Case Study
See how a cosmetics company navigated the new MoCRA compliance landscape.
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